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Kit for the Preparation of Technetium Tc 99m Sestamibi Injection

INDICATIONS AND USAGE

Technetium Tc 99m Sestamibi Injection is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing  myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. Technetium Tc 99m Sestamibi evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (e.g., exercise or pharmacologic stress in accordance with the pharmacologic stress agent's labeling).

It is usually not possible to determine the age of a myocardial infarction or to differentiate a recent myocardial infarction from ischemia.

Technetium Tc 99m Sestamibi is indicated for planar imaging as a second line diagnostic drug after mammography to assist in the evaluation of breast lesions in patients with an abnormal mammogram or a palpable breast mass.

Technetium Tc 99m Sestamibi is not indicated for breast cancer screening, to confirm the presence or absence of malignancy, and it is not an alternative to biopsy.

IMPORTANT RISK INFORMATION

WARNINGS AND PRECAUTIONS

  • Death has occurred 4 to 24 hours after Tc 99m Sestamibi use and is usually associated with exercise stress testing. Continuous monitoring and treatment should be assured in patients with known or suspected cardiac disease.
  • Pharmacologic induction of cardiovascular stress may be associated with serious adverse events such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction and cerebrovascular events. Caution should be used when pharmacologic stress is selected as an alternative to exercise; it should be used when indicated and in accordance with the pharmacologic stress agent's labeling.
  • Technetium Tc 99m Sestamibi has been associated with acute severe allergic and anaphylactic events of angioedema and generalized urticaria. In some patients the allergic symptoms developed on the second injection during Tc 99m Sestamibi imaging. Caution should be exercised and emergency equipment should be available when administering Technetium Tc 99m Sestamibi. Patients should be asked about the possibility of allergic reactions to the drug before the administration of Technetium Tc 99m.
  • The contents of the vial are intended only for use in the preparation of Technetium Tc 99m Sestamibi and are not to be administered directly to the patient without first undergoing the preparative procedure.
  • Radioactive drugs must be handled with care and appropriate safety measures should be used to minimize radiation exposure to clinical personnel and patients.
  • Contents of the kit before preparation are not radioactive. However, after the Sodium Pertechnetate Tc 99m Injection is added, adequate shielding of the final preparation must be maintained.
  • It is essential to follow directions carefully and to adhere to strict aseptic procedures during preparation.
  • Technetium Tc 99m labeling reactions depend on maintaining the stannous ion in the reduced state. Hence, Sodium Pertechnetate Tc 99m Injection containing oxidants should not be used.
  • Technetium Tc 99m Sestamibi should not be used more than six hours after preparation.
  • Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.
  • Stress testing should be performed only under the supervision of a qualified physician and in a laboratory equipped with appropriate resuscitation and support apparatus.

ADVERSE REACTIONS

  • Serious adverse reactions in include arrhythmia, angioedema, angina, seizure, chest pain, severe hypersensitivity, dyspnea and death.
  • Common adverse reactions include taste perversion, changes in special senses and disorders of body as a whole.

USE IN SPECIFIC POPULATIONS

  • Safety and effectiveness in the pediatric population have not been established.

How Supplied

Distribution Direct
Storage Conditions Store at 15°–25°C (59°–77°F) before and after reconstitution. Protect from light prior to reconstitution.
Expiration Product should be used within six (6) hours of preparation.

Order Information

Description Qty Unit Size Order # 11 Digit NDC
Kit, 30-vial 30 vial 10 mL N092D0 00019909240
Kit, 5-vial 5 vial 10 mL N092B0 00019909220

FREQUENTLY ASKED QUESTIONS

QuestionAnswer
What sizes are available?Tc 99m Sestamibi is packaged in a 10 mL vial. Product is supplied in 5- and 30-vial kits as well as unit dose.
How can I order Mallinckrodt Tc 99m Sestamibi?You may order 5- and 30- vial packs directly through our Customer Service department at 888.744.1414.
Who do I contact for additional safety or usage questions?Call Mallinckrodt Product Monitoring at 800.778.7898.